1. Field of the Invention
The present invention relates to a surgical fastener. In particular, the present invention is directed to a thermal fastener for use in surgical procedures to secure a first component to a second component such that the fastener extends through the first component and at least a portion of the second component.
2. Description of Related Art
An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.
Aortic aneurysms are the most common form of arterial aneurysm and are life threatening. The aorta is the main artery which supplies blood to the circulatory system. The aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen. Among other arterial vessels branching off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the renal arteries, the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries. The iliac arteries, in turn, supply blood to the lower extremities and perineal region.
It is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on aneurysms smaller than 5 cm because no statistical benefit exists in performing such procedures.
Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the aortic aneurysm. A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.
Repair of an aortic aneurysm by surgical means is a major operative procedure. Substantial morbidity accompanies the procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated and the surgery carries attendant risk, certain patients may not be able to tolerate the stress of intra-abdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention.
In recent years, methods have been developed to attempt to treat an aortic aneurysm without the attendant risks of intra-abdominal surgical intervention. Among them are inventions disclosed and claimed in Kornberg, U.S. Pat. No. 4,562,596 for Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair; Lazarus, U.S. Pat. No. 4,787,899 for Intraluminal Graft Device, System and Method; and Taheri, U.S. Pat. No. 5,042,707 for Intravascular Stapler, and Method of Operating Same.
Kornberg discloses an aortic graft comprising a flexible tubular material having a plurality of struts to lend the graft stability and resiliency. The struts have angled hooks with barbs at their upper ends which are securely attached to the inside of the aorta above the aneurysm. Kornberg""s graft is inserted using a tubular device also disclosed in his patent. Komberg, however, only anchors the proximal end of the graft. Kornberg claims that the downward flow of blood holds the distal graft securely in place, so that no mechanical attachment is necessary distally. The blood pressure in the abdominal aorta, however, is typically in the magnitude of 130 mm of mercury (Hg). In spite of the direction of flow of blood through the graft, proximal to distal, substantial back pressure within the aneurysm will result unless the distal end is also mechanically attached to the aorta in a manner that prevents substantial leakage of blood between the graft and the aorta. Without distal attachment, the device of Kornberg will not effectively exclude the weakened arterial wall at the site of the aneurysm from the forces and stress associated with the blood pressure.
Lazarus discloses a grafting system that employs a plurality of staples mounted in the proximal end of the graft. Lazarus""s staples are forced through the aorta wall by means of a balloon catheter. As does Komberg, Lazarus discloses staples mounted only in the proximal end of the graft. There is no teaching or suggestion in Lazarus. U.S. Pat. No. 4,787,899 as to the desirability of, let alone means for, mechanically attaching the graft to the distal aorta below the level of the aneurysm.
Taheri discloses an articulatable stapler for implanting a graft in a blood vessel. The stapler is in the form of an elongated catheter with a plurality of segments mounted on the distal end of the catheter. The segments have beveled faces and are connected to each other by hinges. A stylet runs through the catheter to the most distal segment. The most distal segment is moved, in conjunction with the other segments, into a firing position that is substantially perpendicular to the main catheter body by the action of pulling on the stylet. The staple is implanted by using two other stylets which act as fingers to bend the staple into its attachment position.
Taheri, however, appears to be a single-fire design which can only implant one staple at a time. After each stapler is implanted, Taheri""s design apparently requires that the catheter be removed before another staple is loaded. In addition, Taheri""s does not teach or suggest an appropriate density of staples to secure a graft against the pulsatile blood flow of the aorta. Pressures within the aorta range from 120 mm Hg pressure to 200 mm Hg pressure. Without adequate attachment, the graft may leak around the edges continuing to allow life threatening pressures to develop in the aneurysm, and may not even remain in place.
Hence, although in recent years certain techniques have been developed that may reduce the stress, morbidity, and risk of mortality associated with surgical intervention to repair aortic aneurysms, none of the systems that have been developed effectively treat the aneurysm and exclude the affected section of aorta from the pressures and stresses associated with circulation. None of the devices disclosed in the references provide a reliable and quick means to reinforce an aneurysmal artery. In addition, all of the prior references require a sufficiently large section of healthy aorta surrounding the aneurysm to ensure attachment of the graft. The neck of the aorta at the cephalad end (i.e., above the aneurysm) is usually sufficient to maintain a graft""s attachment means. However, when an aneurysm is located near the iliac arteries, there may be an ill-defined neck or no neck below the aneurysm. Such an ill-defined neck would have an insufficient amount of healthy aortic tissue to which to successfully mount a graft. Furthermore, much of the abdominal aorta wall may be calcified which may make it extremely difficult to attach the graft to the wall.
There are a number of shortcomings with the presently available graft products and their fixation within the abdominal aorta. Although sizing of xe2x80x9ctubexe2x80x9d or xe2x80x9cbifurcatedxe2x80x9d grafts is radiographically assessed prior to surgery, it is necessary for the surgeon to have a large selection of graft lengths and diameters on hand to ensure an appropriate surgical outcome. Additional shortcomings include the placement of a xe2x80x9ccircularxe2x80x9d profile graft with an associated fixation device within an essentially xe2x80x9covoidxe2x80x9d profile vessel and the use of attachment means which fasten only to the insubstantial, structurally compromised (diseased) intima and media levels of the vessel wall. Research has exposed yet another problem which indicates that the necks of the post-surgical aorta increase in size for approximately twelve months, regardless of whether the aneurysm experiences dimensional change. This phenomenon can result in perigraft leaks and graft migration.
It is an object of the present invention to provide a fastener that can be thermally positioned to secure a surgical component to a vessel.
It is an object of the present invention to firmly fasten a graft to the adventitia of the vessel wall to prevent migration of the graft.
It is another object of the present invention to provide fastener assemblies that replace sutures.
It is another object of the present invention to provide a fastener assembly that secures a first component to a second component.
It is another object of the present invention to provide a fastener assembly having means to prevent its removal once in an inserted position.
It is another object of the present invention to provide a fastener assembly having means for promoting tissue ingrowth.
It is another object of the present invention to provide a fastener assembly that uses the generation of heat to enable its insertion.
It is another object of the present invention to provide a fastener assembly having a heat transmitting portion.
It is another object of the present invention to provide a fastener assembly having a heat transmitting portion that creates an incision in a first component and a portion of a second component.
It is another object of the present invention to provide a fastener assembly that is safe, reliable and easy to manufacture and use.
It is another object of the present invention to provide a fastener assembly having a low intraluminal profile.
It is another object of the present invention to provide a fastener assembly exerting sufficient force to serve a first component to a second component.
It is another object of the present invention to provide a fastener assembly that is capable of penetrating the adventitial side of the aortic wall.
It is another object of the present invention to provide a fastener assembly that has increased resistance to pull out.
The present invention is directed to a fastener assembly for use during a surgical procedure for securing a first component to a second component. The fastener assembly includes a fastening assembly for securing the first component to the second component under a force. The fastening assembly has a first portion located on one side of the first component and the second component, a second portion located on another side of the first component and the second component, and an intermediate portion connecting to the first portion and the second portion. The intermediate portion extends through the second component and the first component. The first portion, the second portion and the intermediate portion act to apply a compressive force to the first component and the second component to secure the first component to the second component. In accordance with the present invention, at least one of the first portion, the second portion and the intermediate portion of fastening assembly is flexible.
In accordance with the present invention, at least one of the first portion, the second portion and the intermediate portion is formed from a flexible spring assembly. The flexible spring assembly may be a coil spring. The flexible spring assembly may also be at least two coil springs entwined together.
In accordance with the present invention, the fastener assembly may have a first orientation for inserting the fastener assembly through the second component and the first component, and a second orientation when the fastener assembly is in a secured position. The fastener assembly is in a compressed state when in the first orientation and an expanded state when in the second orientation.
The present invention further includes an assembly for preventing removal of the fastener assembly from the first component and the second component. The assembly for preventing removal may include at least one projection located on one of the first portion, the second portion and the intermediate portion. The assembly for preventing removal may include at least one aperture in one of the first portion, the second portion and the intermediate portion. The at least one aperture may promote tissue in-growth.
In accordance with the present invention, the second portion of the fastening assembly may comprise a disk assembly, wherein the disk assembly is located on one side of the first component and the second component. The disk assembly may further include an assembly for preventing removal of the fastener assembly from the first component and the second component. The assembly for preventing removal may include at least one projection extending from the disk assembly. The assembly for preventing removal may include at least one aperture in one the disk assembly.
In accordance with the present invention, the first portion of the fastening assembly may comprise a spear portion. The second portion of the fastening assembly may comprise a base portion. The base portion may be circular, square, rectangular, or trapezoidal in cross-section.
In accordance with the present invention, the fastener assembly may contain at least two arms. In accordance with the present invention, the fastener assembly may be a drill fastener assembly.
In accordance with the present invention, the spear portion may contain a longitudinal slit separating the spear portion into a first spear portion and a second spear portion. The first spear portion and the second spear portion may be adjacent to one another in the first orientation, and may expand away from one another in the second orientation. The base portion may contain a longitudinal slit separating the base portion into a first base portion and a second base portion. The first base portion and the second base portion may be adjacent to one another in the first orientation, and may expand away from one another in the second orientation.
In accordance with the present invention, the transition between said first orientation and said second orientation may be effected by at least one of the presence of heat, moisture, electrical current, injection of a material, torsion, deformation, expansion, friction, and mechanical pressure.